Upcoming Sickle Cell trial
All:
A rather intriguing and important result came out of the sickle cell phase II trial last year which tested Cordox's analgesic effects in patients with sickle cell crisis. Just to refresh everyone's memory, the trial enrolled 47 patients in 7 centers, was placebo-controlled and double blinded. The treatment goup received 3 different doses, 50mg/kg, 100mg/kg and 250mg/kg and the results showed that compared
with placebo, Cordox significantly relieved pain on two different scales. This pain relief occurred within 2 hours of drug administration and appeared to last up to 4 to 16 hours. Curiously, the lowest dose (50mg/kg) was shown to be most effective, followed by the next highest dose, 100 mg/kg, and get this, the highest dose(250mg/kg) proved to produce no pain relief at all (i.e. pain relief was statistically insignificant compared with placebo). In light of these results which are consistant with an inverted "U" shaped dose-response curve for Cordox, I am wondering which doses will be tested in the upcoming Phase 3 trial. Perhaps it would be wise to test doses less than 50mg/kg to see if such lower doses produce even greater analgesia. Also, would anyone like to posit a theory explaining this interesting dose-response relationship? Moreover, in the several other clinical trials testing Cordox's effects in Acute MI, CHF, and CABG, were other doses tested? If not, perhaps the doses
they tested were not optimal. Given the astounding results from these trials, the prospect of achieving even better outcomes by altering the dose is very exciting. Your thoughts?
--Drug Doc |
